Status:
COMPLETED
BDB001-201: A Clinical Study of BDB001 in Patients With PD-(L)1 Refractory Solid Tumors
Lead Sponsor:
Eikon Therapeutics
Conditions:
Tumor, Solid
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
BDB001-201 is a multi-center, open-label, Phase II clinical trial to evaluate the efficacy and safety of BDB001 in the treatment of subjects with advanced solid tumors that have progressed on anti-PD-...
Detailed Description
BDB001-201 is a multi-center, open-label, multi-arm Phase II study evaluating an experimental immunotherapy drug called BDB001. BDB001 is a Toll-like receptor 7/8 (TLR7/8) agonist delivered intravenou...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Histologically or cytologically confirmed: Cutaneous SCC, Head and Neck SCC, Melanoma, Merkel Cell Carcinoma, NSCLC, Renal Cell Carcinoma, or Urothelial Carcinoma. Other tumor types will be allowed at Sponsor's discretion.
- Tumor progression on the most recent line of treatment with anti-PD-1 or anti-PD-L1 mAb as monotherapy or in combination.
- Eastern Cooperative Oncology Group (ECOG) score of 0 - 2
- At least 1 lesion with measurable disease at baseline
- Availability of a lesion for biopsy and consent to allow pre-treatment tumor biopsy.
- Exclusion Criteria
- Participants are excluded from the study if any of the following criteria apply:
- Greater than 4 lines of prior DNA-damaging chemotherapies.
- Uncontrolled CNS metastases.
- Active autoimmune disease.
- Other protocol defined inclusion/exclusion criteria could apply
Exclusion
Key Trial Info
Start Date :
August 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2023
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04819373
Start Date
August 30 2021
End Date
May 1 2023
Last Update
November 12 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030